Anavex Life Sciences

Anavex Life Sciences has successfully completed enrollment of 71 participants in its Phase 2 clinical study of ANAVEX®3-71 for schizophrenia treatment, with top-line data expected in the second half of 2025.

Alzheon is set to present Phase 3 trial data for ALZ-801 in April 2025, a drug designed to prevent the formation of toxic beta-amyloid plaques in early Alzheimer's patients with the ApoE4 gene.

• Anavex Life Sciences' blarcamesine demonstrates sustained cognitive and functional benefits in early Alzheimer's patients over three years of continuous oral treatment. • The European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) for blarcamesine, a potential novel oral treatment for Alzheimer's disease. • Blarcamesine targets upstream Alzheimer's pathology through autophagy enhancement and has shown a favorable safety profile in clinical trials. • Anavex is also evaluating blarcamesine for other CNS indications, including Parkinson’s disease and Rett syndrome.

Anavex Life Sciences' blarcamesine demonstrates significant reduction in clinical decline over three years for early Alzheimer's patients.

The European Medicines Agency (EMA) has accepted Anavex's Marketing Authorization Application (MAA) for blarcamesine to treat Alzheimer's disease.

Anavex Life Sciences Corp. reported a reduced net loss of $43.0 million for fiscal year 2024, driven by decreased operating expenses and increased other income.

• Over 120 Alzheimer's Disease treatment therapies are under development by 110+ companies globally, ranging from preclinical to marketed phases. • Emerging therapies like NRDN-201, ST-501, and KarXT are in various clinical trial phases, showing potential for significant market impact. • MapLight Therapeutics initiated a Phase 1 trial for ML-007/PAC, targeting schizophrenia and Alzheimer's disease psychosis, with Phase 2 trials planned. • The FDA granted conventional approval to Leqembi (lecanemab-irmb), marking the first amyloid beta-directed antibody to transition from accelerated approval.

• ShiraTronics has initiated its RELIEV-CM2 study, implanting its neuromodulation device in chronic migraine patients across the US and Australia to assess therapeutic effects. • QurAlis' QRL-201, designed to restore STATHMIN-2 expression, advances to the dose range-finding phase of its ANQUR trial for ALS after successful dose-escalation. • Anavex Life Sciences has submitted a marketing authorization application to the EU for blarcamesine as a potential treatment for Alzheimer's disease, based on Phase 2/3 trial data.

Anavex Life Sciences announced the acceptance of a peer-reviewed manuscript detailing Phase IIb/III trial results of oral blarcamesine for early Alzheimer's disease.

Anavex Life Sciences is developing Anavex 2-73, a small molecule targeting the sigma-1 receptor, for neurodegenerative and neurodevelopmental disorders.